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临床试验/NCT02910076
NCT02910076Unknown1 期

The Influence of Plaquenil/Hydroxychloroquine (HCQ) on Insulin Secretion

Hadassah Medical Organization0 个研究点目标入组 40 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
40
主要终点
glucose level

研究概览

简要总结

Antimalarials such as hydroxychloroquine (HCQ), are among the oldest prescribed drugs still used in clinical practice. Relatively inexpensive and well tolerated, these drugs have been recognized to be effective in autoimmune diseases such as rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Interestingly, there is growing evidence of their beneficial impact on cardiovascular risk, particularly diabetes. HCQ therapy can improve balance in patients with unbalanced diabetes. This drug therapy may be a new therapeutic approach for diabetes. There is need for a better understanding of the mechanisms responsible for the improvement of the metabolic response to drug treatment. The investigators hypothesize that treatment with a drug improves the function of the beta cell and its ability to secrete insulin in response to glucose. The investigators will examine the impact of short-term therapy for HCQ in beta cell function in healthy volunteers and in patients with type 2 diabetes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Age: 18-40
  • Without acute disease at the day of the experiment.
  • Signed informed consent

排除标准

  • Malignancy
  • Steroids or NSAID on a daily basis
  • B. Diabetes patients
  • Inclusion Criteria:
  • Age: 20-60
  • Diabetes type two
  • Untreated or on metformin treatment
  • Exclusion Criteria:
  • Hypoglycemic medications

研究组 & 干预措施

Healthy volunteers

Experimental

干预措施: Hydroxychloroquine (Drug)

Diabetes patients

Experimental

干预措施: Hydroxychloroquine (Drug)

结局指标

主要结局

glucose level

时间窗: the change in glucose level between baseline and after three hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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